BD FACSCALIBUR¿ FLOW CYTOMETER

Additional Manufacturer Narrative

H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR ERRONEOUS RESULTS OCCURRED AND REPORTED TO THE DOCTOR. NO PATIENT TREATMENT DELAY AND NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE WAS SAMPLE FROM ONE PATIENT WHERE CD4+ WAS NOT DETECTED EVEN THOUGH IT WAS CONFIRMED BY OTHER LABORATORY THAT THESE ARE PRESENT. AT THE MOMENT IT IS NOT KNOWN WHERE THE FAULT LIES (SAMPLE PREPARATION, ANTIBODIES (BOUGHT FROM BD) OR ON THE INSTRUMENT ITSELF, THUS THE CASE IS BEING OPEN FOR INVESTIGATION PURPOSES. THE CD4 WAS NOT DETECTED IN THE BLOOD SAMPLE FROM ONE PATIENT (BUT WAS FOUND IN THE DIFFERENT LABORATORY IN FRANKFURT). THE CONTROLS WERE DETECTED SO CUSTOMER DOES NOT UNDERSTAND WHY IT HAPPENED AND TRIES TO GET TO THE BOTTOM OF THIS. THE DOCTOR WAS INFORMED - NO TREATMENT WAS AFFECTED BY THE ISSUE.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR ERRONEOUS RESULTS OCCURRED AND REPORTED TO THE DOCTOR. NO PATIENT TREATMENT DELAY AND NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE WAS SAMPLE FROM ONE PATIENT WHERE CD4+ WAS NOT DETECTED EVEN THOUGH IT WAS CONFIRMED BY OTHER LABORATORY THAT THESE ARE PRESENT. AT THE MOMENT IT IS NOT KNOWN WHERE THE FAULT LIES (SAMPLE PREPARATION, ANTIBODIES (BOUGHT FROM BD) OR ON THE INSTRUMENT ITSELF, THUS THE CASE IS BEING OPEN FOR INVESTIGATION PURPOSES. THE CD4 WAS NOT DETECTED IN THE BLOOD SAMPLE FROM ONE PATIENT (BUT WAS FOUND IN THE DIFFERENT LABORATORY IN FRANKFURT). THE CONTROLS WERE DETECTED SO CUSTOMER DOES NOT UNDERSTAND WHY IT HAPPENED AND TRIES TO GET TO THE BOTTOM OF THIS. THE DOCTOR WAS INFORMED - NO TREATMENT WAS AFFECTED BY THE ISSUE.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ERRONEOUS RESULTS WAS NOT CONFIRMED. BASED ON AN ANALYSIS OF THE PROVIDED CUSTOMER DATA BY APPLICATIONS SUPPORT AND TECHNICAL SUPPORT, NO ISSUE COULD BE FOUND WITH THIS INSTRUMENT. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR ERRONEOUS RESULTS OCCURRED AND REPORTED TO THE DOCTOR. NO PATIENT TREATMENT DELAY AND NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE WAS SAMPLE FROM ONE PATIENT WHERE CD4+ WAS NOT DETECTED EVEN THOUGH IT WAS CONFIRMED BY OTHER LABORATORY THAT THESE ARE PRESENT. AT THE MOMENT IT IS NOT KNOWN WHERE THE FAULT LIES (SAMPLE PREPARATION, ANTIBODIES (BOUGHT FROM BD) OR ON THE INSTRUMENT ITSELF, THUS THE CASE IS BEING OPEN FOR INVESTIGATION PURPOSES. THE CD4 WAS NOT DETECTED IN THE BLOOD SAMPLE FROM ONE PATIENT (BUT WAS FOUND IN THE DIFFERENT LABORATORY IN FRANKFURT). THE CONTROLS WERE DETECTED SO CUSTOMER DOES NOT UNDERSTAND WHY IT HAPPENED AND TRIES TO GET TO THE BOTTOM OF THIS. THE DOCTOR WAS INFORMED - NO TREATMENT WAS AFFECTED BY THE ISSUE.